Author: TrialSphere

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What Are Virtual Clinical Trials? An Interview with Science 37’s Jonathan Cotliar

What Are Virtual Clinical Trials? An Interview with Science 37’s Jonathan Cotliar

The majority of clinical trials are conducted at major research institutions or clinics, often based in urban areas. This can create problems of accessibility for many potential patients who live more than two hours from a trial site or who have work and family responsibilities that make it difficult for them to participate. It also creates significant issues in terms of patient diversity. In early June, the U.S. Food and Drug Administration (FDA) issued a draft guidance on improving the diversity of patient populations in clinical trials. The biggest focus is on getting sponsor companies to include more historically underserved populations in clinical trials, including women, the elderly and minorities. The 18-page guidance makes numerous recommendations, including enrichment, inclusive trial practices and design, and methodological ways to bring in a wider range of patient populations. One of the first recommendations under “Make Trial Participation Less Burdensome for Participants,” is to take into consideration recruitment challenges that might be caused by a planned visit schedule. The guidance states: “Reduce the frequency of study visits to those needed to appropriately monitor safety and efficacy and consider whether flexibility in visit windows is possible and whether electronic communication (e.g., telephone/mobile telephone, secured electronic mail, social media platforms) or mobile technology tools can be used to replace site visits and provide investigators with real-time data.” Jonathan Cotliar , chief medical officer of Science 37 , a technology-enabled virtual trial research company, took time to talk with BioSpace about virtual clinical trials and the role telemedicine, a platform designed specifically to operationalize virtual trials, and biowearables, can play in clinical trials. “Science 37 was founded almost five years ago by two physician-scientists who understood that clinical trials had a variety of problems—primarily drugs were taking too long to get to the market, were too […]

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Google sister-company Verily is teaming with big pharma on clinical trials

Google sister-company Verily is teaming with big pharma on clinical trials

Google sister-company Verily is teaming with big pharma on clinical trials

“The clinical trials marketplace and vendor space hasn’t been disrupted in quite some time, said Tom Cassels, chief strategy officer for a company called Leidos, which specializes in health technology. “So the opportunity to both improve the efficacy and speed of clinical trials is attractive, and it’s a huge market.”

CMO at Verily, Jessica Mega speaks onstage during JDRF LA’s IMAGINE Gala to benefit type 1 diabetes research at The Beverly Hilton on May 14, 2016 in Beverly Hills, California. CMO at Verily, Jessica Mega speaks onstage during JDRF LA’s IMAGINE Gala to benefit type 1 diabetes research at The Beverly Hilton on May 14, 2016 in Beverly Hills, California. Todd Williamson | Getty Images Verily, the health and life sciences company under Google parent-company Alphabet , is moving into the clinical trials space. The company announced Tuesday strategic alliances with the pharmaceutical companies Novartis, Sanofi, Otsuka and Pfizer to help it move more deeply into the medical studies market. The goals for Verily, and its pharma partners, are to reach patients in new ways, make it easier to enroll and participate in trials, and aggregate data across a variety of sources, including the electronic medical record or health-tracking wearable devices. Clinical trials have historically been expensive processes that rely on outdated technologies. So pharma companies are looking to leverage the latest technologies from companies like Google to reach patients in a more targeted way and get their most promising drugs approved more quickly. That’s where Verily comes in. […]

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How MIT researchers used AI to improve drug approvals

How MIT researchers used AI to improve drug approvals

Machine learning is being quickly adapted across the healthcare space to develop precision medicine, and it can also be leveraged to improve the development of new drug treatments and devices by improving the randomized clinical trial process, according to MIT researchers. The researchers needed to enhance data on clinical trial outcomes to better predict if drugs were likely to be approved, using machine learning and statistical techniques.

Limiting the risks of clinical trials can allow resources to be used more efficiently, with fewer failures, faster drug approval times, lower cost of capital and more funding for developing other new therapies.

They used the largest set of data to date from two proprietary pharma pipeline databases. The findings were published in the debut issue of the Harvard Data Science Review . Limiting the risks of clinical trials can allow resources to be used more efficiently, with fewer failures, faster drug approval times, lower cost of capital and more funding for developing other new therapies. “Everyone is affected by the risk of a drug failing in its clinical trial process,” lead study author Andrew Lo, director of the MIT Laboratory for Financial Engineering, said in a statement. “With more accurate measures of the risk of drug and device development, we hope to encourage greater investment at this unique inflection point in biomedicine.” Beyond offering guidance to investors, scientists, clinicians and biopharma professionals on the […]

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Five Ways Voice Assistants Can Change Drug Research

Five Ways Voice Assistants Can Change Drug Research

Voice-powered virtual assistants have huge potential for improving and expanding clinical trials, and tech companies are moving quickly to develop artificial intelligence-based software that can support and also protect the most private conversations between patients and clinicians. Katherine Vandebelt has already started scribbling down ideas about how voice assistants could work in a clinical trial environment. As Oracle’s global head of clinical innovation, and former clinical innovation leader at Eli Lilly and Company, Vandebelt believes that the clinical trial experience can change with the introduction of virtual assistants into the drug research ecosystem. Oracle In April, Amazon’s Alexa app became compliant with the US government’s Health Insurance Portability and Accountability Act (HIPAA), and similar virtual assistants are likely to follow. Here are five changes she sees coming. 1. Helping Healthcare Providers Run Their Day People who are executing a clinical trial—the ones seeing patients and collecting data—will use a virtual assistant to organize their day in the same way that many people start their day by asking Amazon’s Alexa or Apple’s Siri for the weather or the news. By integrating a voice-powered digital assistant as the interface to a clinical trial management system, providers could ask what patients they’re […]

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Combatting The Professional Patient Problem In Clinical Trials

Combatting The Professional Patient Problem In Clinical Trials

Combatting The Professional Patient Problem In Clinical Trials

Clinical research patients are compensated for their participation in clinical trials. The compensation is based on the burden the trial imposes on the patient and is vetted through an institutional review board, so patients are not overly influenced by financial gain to enroll. Unfortunately, in some therapeutic areas and types of clinical trials, the compensation for enrolling in one or more clinical trials or at multiple research sites is enough to influence patients to join more than one contemporaneously and expose themselves to multiple investigational products or multiple doses of one investigational product. In other cases, patients may participate in several clinical trials but never actually take the investigational product, providing false answers and data just to remain in the trial. These “professional patients” are a growing threat to the safety of patients in clinical research and the data integrity of trials. (Even HBO’s show Vice highlighted professional patients in a season 6 episode called “Lab Rat Nation.”) With increasing pressures to recruit subjects in a timely fashion along with the abundance of social media, research participants have increased the incidence of simultaneously enrolling

The hard costs of a failed clinical trial are easily quantifiable, but there are costs that are much more difficult to quantify such as lost time to market to generate sales of the investigational product and damage to the company’s stock price and investor confidence. Eliminating professional patients should not only be the research sites’ responsibility but also the responsibility of the pharmaceutical or biotech company. Professional patients are becoming more educated on how to enter clinical trials due to social media. And, due to the financial compensation and cost of healthcare, professional patients are very interested in enrolling in clinical trials. Incorporating a proactive prescreening service such as a research subject database is vital to eliminating professional patients from your clinical trial. There needs to be adequate awareness and protection across all phases of clinical trials research from phase 1 through 3 to prevent data quality issues and improve research volunteer safety.

in more than one clinical trial at a time. Many patients do not have the […]

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Google launches new search engine to help scientists find the datasets they need

Speaking to The Verge, Natasha Noy, a research scientist at Google AI who helped create Dataset Search, says the aim is to unify the tens of thousands of different repositories for datasets online. “We want to make that data discoverable, but keep it where it is,” says Noy.

Illustration by Alex Castro / The Verge Google’s goal has always been to organize the world’s information, and its first target was the commercial web. Now, it wants to do the same for the scientific community with a new search engine for datasets. The service, called Dataset Search , […]

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Google’s DeepMind to create AI product to spot eye disease

DeepMind plans to develop a product that will help doctors detect more than 50 sight-threatening conditions from a common eye scan. DeepMind, the London-based artificial intelligence company that is owned by Alphabet, trained artificial intelligence software to detect signs of disease better than human doctors, according to a study […]

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AI and quantum physics are searching for life-saving drugs

AI and quantum physics are searching for life-saving drugs

When it comes to developing drugs, the human brain is its own worst enemy. Though our pre-frontal cortex – the most complex structure known in nature – has devised countless remedies for the body that keeps it alive, the organ itself is almost impervious to treatment. The […]

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Should Tech Entrepreneurs Aspire To Fix Clinical Trials Or Reinvent Them?

Should Tech Entrepreneurs Aspire To Fix Clinical Trials Or Reinvent Them?

To fix or to reinvent? That’s the question many would-be innovators ask as they contemplate potential applications of technology to health. Boston’s Brigham and Women’s Hospital, home institution to both Dr. Stephen Wiviott, who seeks to fix traditional clinical trials, and Dr. Sebastian Schneeweiss, who is exploring the potential […]